Revolution Medicines · 3 hours ago
Director, Medical Affairs Governance
United States
Full-time
Remote
Director/Executive
$211K/yr - $264K/yr
10+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Director, Medical Affairs Governance will ensure robust governance, compliance, and operational excellence across all Medical Affairs functions, establishing global governance frameworks and leading cross-functional initiatives.
Health CareLife ScienceMedical
Responsibilities
Develop and implement a comprehensive global Medical Governance framework to support strategic and operational excellence across Medical Affairs
Lead governance process for Medical Affairs, including facilitation and coordination of the Medical Project Review Group
Lead governance for all Medical Affairs functions, including medical information, medical education, scientific engagement, congress strategy, and publications
Partner with cross-functional teams (Legal, Compliance, Regulatory) to ensure adherence to industry standards, company policies, and regulatory requirements
Oversee the medical review responsibilities and process for Medical Legal Review committees, ensuring efficient and compliant medical review of materials, communications, and scientific content
Ensure medical activities align with corporate policies and external regulatory guidance, including FDA, EMA, PhRMA Code, ICH, GVP, and other relevant regulations
Establish, maintain, and optimize global Medical Affairs Standard Operating Procedures (SOPs), Work Instructions, and best practices to drive consistency and compliance
Conduct periodic reviews of policies and ensure Medical Affairs teams are trained on key processes
Partner with Compliance on SOP initiatives
Drive continuous improvement efforts to streamline governance frameworks and enhance efficiency within Medical Affairs operations
Lead inspection readiness efforts across Medical Affairs, ensuring processes, documentation, and governance frameworks meet regulatory expectations
Act as a point of contact for regulatory inspections and internal audits, providing oversight and guidance on Medical Affairs-related compliance activities
Collaborate with QA and Compliance to identify risks, implement corrective and preventive actions (CAPAs), and maintain audit readiness
Work across therapeutic areas, geographies, and functions to ensure seamless integration of governance processes within the global Medical Affairs organization
Provide strategic guidance to Medical Affairs leadership on governance best practices and risk mitigation strategies
Act as the key liaison between Medical Affairs, Compliance, Legal, and other internal stakeholders to align governance initiatives across the organization
Qualification
Required
Advanced scientific or medical degree (PhD, PharmD, MD) preferred; MS or equivalent experience in biomedical sciences or related field considered
10+ years of experience in Medical Affairs or related functions within the biotechnology, pharmaceutical, or healthcare industry
Strong background in Medical Governance, Compliance, Regulatory Affairs, or Medical Operations
Experience working in global biotech/pharmaceutical environments, supporting multiple regions and therapeutic areas
Deep knowledge of global regulatory requirements for Medical Affairs, including FDA, EMA, ICH, GVP, and industry best practices
Proven experience developing SOPs, policies, and governance frameworks to support medical organizations
Strong track record in inspection readiness, audits, and compliance oversight for Medical Affairs functions
Ability to navigate complex regulatory and legal environments and advise teams on governance best practices
Experience leading Medical Review Committees (MRCs) or similar governance structures
Strong interpersonal, communication, and leadership skills with the ability to influence cross-functional stakeholders
Preferred
Prior experience in oncology, precision medicine, or targeted therapies
Expertise in digital platforms for compliance tracking, document management, and governance reporting
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase